NCT03496675

Music Interventions for Dementia and Depression in Elderly Care

Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,021 (actual)
• Sponsor: NORCE Norwegian Research Centre AS · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of two music-based approaches - group music therapy and recreational choir singing - for reducing depression symptoms in people living with dementia. It also examines mechanisms and heterogeneity of treatment effects.

Detailed description

Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs. Music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials. The MIDDEL trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (GMT), and recreational choir singing (RCS) - alone and in combination across countries. MIDDEL is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. Study sites will be located in Australia and in five European countries, and a total of 100 care home units will be randomised to one of the four study conditions.

Conditions

• Dementia
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Group Music Therapy	The core intention of GMT is to meet the psychosocial needs of each person living with dementia, which in turn is thought to reduce depressive symptoms and anxiety and to stimulate overall social and emotional wellbeing. It includes active, reciprocal music making with the use of singing and musical instruments. GMT is provided by a trained music therapist, highly skilled as a musician, and registered with the appropriate professional association in his or her country.
BEHAVIORAL	Recreational Choir Singing	RCS is intended to foster connectedness in a group, wellbeing, and enjoyment of music making in a group. It includes singing familiar songs and providing a familiar musical environment for participants. RCS is provided by a musician with choir leading skills.
OTHER	Standard care	May include pharmacological and non-pharmacological interventions as locally available

Timeline

• Start date: 2018-07-18
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2018-04-12
• Last updated: 2025-07-09

Locations

6 sites across 6 countries: Australia, Germany, Netherlands, Norway, Turkey (Türkiye), United Kingdom